The Northern New England Rapid Deployment Valve Experience: Survival and Procedural Outcomes From 2015 to 2021.

OBJECTIVE: The optimal approach and choice of initial aortic valve replacement (AVR) is evolving in the growing era of transcatheter AVR. Further survival and hemodynamic data are needed to compare the emerging role of rapid deployment (rdAVR) versus stented (sAVR) valve options for AVR. METHODS: The Northern New England Cardiovascular Database was queried for patients undergoing either isolated AVR or AVR + coronary artery bypass grafting (CABG) with rdAVR or sAVR aortic valves between 2015 and 2021. Exclusion criteria included endocarditis, mechanical valves, dissection, emergency case status, and prior sternotomy. This resulted in a cohort including 1,616 sAVR and 538 rdAVR cases. After propensity weighting, procedural characteristics, hemodynamic variables, and survival outcomes were examined. RESULTS: The breakdown of the overall cohort (2,154) included 1,164 isolated AVR (222 rdAVR, 942 sAVR) and 990 AVR + CABG (316 rdAVR, 674 sAVR). After inverse propensity weighting, cohorts were well matched, notable only for more patients <50 years in the sAVR group (4.0% vs 1.9%, standardized mean difference [SMD] = -0.12). Cross-clamp (89 vs 64 min, SMD = -0.71) and cardiopulmonary bypass (121 vs 91 min, SMD = -0.68) times were considerably longer for sAVR versus rdAVR. Immediate postreplacement aortic gradient decreased with larger valve size but did not differ significantly between comparable sAVR and rdAVR valve sizes or overall (6.5 vs 6.7 mm Hg, SMD = 0.09). Implanted rdAVR tended to be larger with 51% either size L or XL versus 37.4% of sAVR ≥25 mm. Despite a temporal decrease in pacemaker rate within the rdAVR cohort, the overall pacemaker frequency was less in sAVR versus rdAVR (4.4% vs 7.4%, SMD = 0.12), and significantly higher rates were seen in size L (10.3% vs 3.7%, P < 0.002) and XL (15% vs 5.6%, P < 0.004) rdAVR versus sAVR. No significant difference in major adverse cardiac events (4.6% vs 4.6%, SMD = 0.01), 30-day survival (1.5% vs 2.6%, SMD = 0.08), or long-term survival out to 4 years were seen between sAVR and rdAVR. CONCLUSIONS: Rapid deployment valves offer a safe alternative to sAVR with significantly decreased cross-clamp and cardiopulmonary bypass times. Despite larger implantation sizes, we did not appreciate a comparative difference in immediate postoperative gradients, and although pacemaker rates are improving, they remain higher in rdAVR compared with sAVR. Longer-term hemodynamic and survival follow-up are needed.

Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

Multicenter experience with valve-in-valve transcatheter aortic valve replacement compared with primary, native valve transcatheter aortic valve replacement.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) offers an alternative to reoperative surgical aortic valve replacement. The short- and intermediate-term outcomes after ViV TAVR in the real world are not entirely clear. PATIENTS AND METHODS: A multicenter, retrospective analysis of a consecutive series of 121 ViV TAVR patients and 2200 patients undergoing primary native valve TAVR from 2012 to 2017 at six medical centers. The main outcome measures were in-hospital mortality, 30-day mortality, stroke, myocardial infarction, acute kidney injury, and pacemaker implantation. RESULTS: ViV patients were more likely male, younger, prior coronary artery bypass graft, "hostile chest," and urgent. 30% of the patients had Society of Thoracic Surgeons risk score <4%, 36.3% were 4%-8% and 33.8% were >8%. In both groups many patients had concomitant coronary artery disease. Median time to prosthetic failure was 9.6 years (interquartile range: 5.5-13.5 years). 82% of failed surgical valves were size 21, 23, or 25 mm. Access was 91% femoral. After ViV, 87% had none or trivial aortic regurgitation. Mean gradients were <20 mmHg in 54.6%, 20-29 mmHg in 30.6%, 30-39 mmHg in 8.3% and ≥40 mmHg in 5.87%. Median length of stay was 4 days. In-hospital mortality was 0%. 30-day mortality was 0% in ViV and 3.7% in native TAVR. There was no difference in in-hospital mortality, postprocedure myocardial infarction, stroke, or acute kidney injury. CONCLUSION: Compared to native TAVR, ViV TAVR has similar peri-procedural morbidity with relatively high postprocedure mean gradients. A multidisciplinary approach will help ensure patients receive the ideal therapy in the setting of structural bioprosthetic valve degeneration.

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

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Prolonged Cardiopulmonary Bypass is Associated With Endothelial Glycocalyx Degradation.

BACKGROUND: The endothelial glycocalyx (EG) is involved in critical regulatory mechanisms that maintain endothelial vascular integrity. We hypothesized that prolonged cardiopulmonary bypass (CPB) may be associated with EG degradation. We performed an analysis of soluble syndecan-1 levels in relation to duration of CPB, as well as factors associated with cell stress and damage, such as mitochondrial DNA (mtDNA) and inflammation. METHODS: Blood samples from subjects undergoing cardiac surgery with CPB (n = 54) were obtained before and during surgery, 4-8 h and 24 h after completion of CPB, and on postoperative day 4. Flow cytometry was used to determine subpopulations of white blood cells. Plasma levels of mtDNA were determined using quantitative polymerase chain reaction and plasma content of shed syndecan-1 was measured. To determine whether syndecan-1 was signaling white blood cells, the effect of recombinant syndecan-1 on mobilization of neutrophils from bone marrow was tested in mice. RESULTS: CPB is associated with increased mtDNA during surgery, increased syndecan-1 blood levels at 4-8 h, and increased white blood cell count at 4-8 h and 24 h. Correlation analysis revealed significant positive associations between time on CPB and syndecan-1 (rs = 0.488, P < 0.001) and level of syndecan-1 and neutrophil count (rs = 0.351, P = 0.038) at 4-8 h. Intravenous administration of recombinant syndecan-1 in mice resulted in a 2.5-fold increase in the number of circulating neutrophils, concurrent with decreased bone marrow neutrophil number. CONCLUSIONS: Longer duration of CPB is associated with increased plasma levels of soluble syndecan-1, a signal for EG degradation, which can induce neutrophil egress from the bone marrow. Development of therapy targeting EG shedding may be beneficial in patients with prolonged CPB.

Repair of Spontaneous Left Atrial Dissection Resulting in Severe Paravalvular Native Mitral Valve Regurgitation.

A 54-year-old male with history of end-stage renal disease secondary to hypertension on hemodialysis with moderate aortic valve insufficiency presented with progressive exertional dyspnea and lower extremity edema over several weeks. Relevant history included hospitalization for Staphylococcus epidermidis bacteremia secondary to dialysis catheter line infection 6 months prior. (Level of Difficulty: Advanced.).

The 30-Year Influence of a Regional Consortium on Quality Improvement in Cardiac Surgery.

BACKGROUND: The Northern New England Cardiovascular Disease Study Group (NNECDSG) was founded in 1987 as a regional consortium to improve cardiovascular quality in Maine, New Hampshire, and Vermont. We sought to assess the longitudinal impact of the NNECDSG on quality and cost of coronary artery bypass grafting (CABG) during the past 30 years. METHODS: Patients undergoing isolated CABG at 5 medical centers from 1987-2017 were retrospectively reviewed (n = 67,942). They were divided into 4 time periods: 1987-1999 (n = 36,885), 2000-2005 (n = 14,606), 2006-2011(n = 8470), and 2012-2017 (n = 7981). The first period was the time the NNECDSG initiated a series of quality improvement initiatives including data feedback, quality improvement training, process mapping, and site visits. RESULTS: Throughout the 4 time intervals, there was a consistent decline in in-hospital mortality, from 3.4% to 1.8% despite an increase in predicted risk of mortality (P < .001), and a significant decline in in-hospital morbidity, including return to the operating room for bleeding, acute kidney injury, mediastinitis, and low output failure (P < .001). Median length of stay decreased from 7 to 5 days (P < .001), which translated into potential savings of $82,722,023. There was a decrease in use of red blood cells from 3.1 units to 2.6 units per patient in the most current time, which translated into potential savings of $1,985,456. CONCLUSIONS: By using collaborative quality improvement initiatives, the NNECDSG has succeeded in significant, sustained improvements in quality and cost for CABG during the past 30 years. These data support the utility of a regional consortium in improving quality.

Surgical Atrial Fibrillation Ablation Improves Long-Term Survival: A Multicenter Analysis.

BACKGROUND: The Society of Thoracic Surgeons guidelines recommend surgical ablation (SA) at the time of concomitant mitral operations, aortic valve replacement, coronary artery bypass grafting (CABG), and aortic valve replacement plus CABG for patients in atrial fibrillation (AF). The goal of this analysis was to assess the influence of SA on long-term survival. METHODS: A retrospective analysis of 20,407 consecutive CABG or valve procedures from 2008 to 2015 among seven centers reporting to a prospectively maintained clinical registry was conducted. Patients undergoing operation with documented preoperative AF were included (n = 2,740). Patients receiving SA were compared with patients receiving no SA. The primary end point was all-cause mortality. Secondary end points included in-hospital morbidity and mortality. RESULTS: The frequency of SA was 23.1% (n = 634), and an increase was seen in the rate of SA over the study period (p < 0.001). Concomitant SA was performed in 16.2% of CABG, 30.6% of valve, and 24.3% of valve plus CABG procedures. A substantial improvement was found in unadjusted survival among patients undergoing SA (hazard ratio 0.54, 95% confidence interval: 0.42 to 0.70). Moreover, no differences were found in postoperative complications. SA did have longer bypass times (p < 0.001) but a shorter overall length of stay (p < 0.001). After risk adjustment, SA patients had an improved 5-year survival (hazard ratio 0.69, 95% confidence interval: 0.51 to 0.92), and the effect was observed across all operations. CONCLUSIONS: In a multicenter cohort of patients with AF, concomitant SA resulted in substantially improved long-term survival across patients who underwent CABG, valve, and valve plus CABG. These findings support current guidelines from The Society of Thoracic Surgeons that recommend broader application of concomitant SA.

Intensity of Glycemic Control Affects Long-Term Survival After Coronary Artery Bypass Graft Surgery.

BACKGROUND: A patient's hemoglobin (Hb) A1c level, regardless of diabetic status, is a measure of glycemic control. Studies have found it is an independent predictor of short-term death in patients undergoing coronary artery bypass grafting (CABG). In this study, we used preoperative HbA1c to assess whether levels are associated with short-term and long-term survival after CABG. METHODS: From a regional registry of consecutive cases, we identified 6,415 patients undergoing on-pump isolated CABG from 2008 to 2015 with documented preoperative HbA1c level. We defined four HbA1c groups: less than 5.7% (n = 1,713), 5.7% to 6.4% (n = 2,505), 6.5% to 8.0% (n = 1,377), and more than 8% (n = 820). Relationship to in-hospital outcomes and long-term survival was assessed. Outcome rates and hazard ratios were adjusted for patient and disease risk factors using multivariable logistic regression and Cox models. RESULTS: The study included 3,740 patients (58%) not diagnosed as having diabetes and 2,674 with diabetes. Prediabetes (HbA1c 5.7% to 6.4%) was documented in 52% (n = 1,933) of nondiabetic patients. Higher HbA1c values were associated with younger age, female sex, greater body mass index, more comorbid diseases, lower ejection fraction, more 3-vessel coronary disease, and recent myocardial infarction (p < 0.05 trend for all). After adjustment for patient risk, greater HbA1c values were not associated with higher rates of in-hospital death or morbidity. Long-term survival was significantly worse as HbA1c increased. Risk of death increased by 13% for every unit increase in HbA1c (adjusted hazard ratio, 1.13; 95% confidence interval, 1.07 to 1.19; p < 0.001). CONCLUSIONS: Preadmission glycemic control, as assessed by HbA1c, is predictive of long-term survival, with higher levels associated with poorer prognosis. Whether this risk can be modified by better glycemic control postoperatively remains to be determined.

Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement.

BACKGROUND: The burden oral anticoagulation is a limitation of mechanical valve prostheses. OBJECTIVES: The aim of this study was to test whether patients could be safely managed with dual-antiplatelet therapy (DAPT) (aspirin 325 mg and clopidogrel 75 mg) or lower warfarin after On-X mechanical aortic valve replacement (mAVR). METHODS: PROACT (Prospective Randomized On-X Anticoagulation Trial) (n = 576) is a multicenter (41 sites) noninferiority trial. From June 2006 through February 2014, 201 patients ≥18 years of age without thromboembolic risk factors undergoing mAVR were randomized to receive DAPT (n = 99) or standard warfarin plus aspirin (n = 102) 3 months after mAVR (low-risk arm). From June 2006 through October 2009, 375 patients with 1 or more thromboembolic risk factors were also randomized to lower intensity warfarin plus aspirin (international normalized ratio 1.5 to 2.0; n = 185) or standard warfarin plus aspirin (international normalized ratio 2.0 to 3.0; n = 190) 3 months after mAVR (high-risk arm). RESULTS: The low-risk arm was terminated for excess cerebral thromboembolic events (3.12% per patient-year vs. 0.29% per patient-year, p = 0.02) in the DAPT group at up to 8.8-year follow-up (631.6 patient-years), with no differences in bleeding or all-cause mortality. High-risk arm patients experienced significantly lower major (1.59% per patient-year vs. 3.94% per patient-year, p = 0.002) and minor (1.27% per patient-year vs. 3.49% per patient-year, p = 0.002) bleeding up to 8.7-year follow-up (2,035.2 patient-years), with no differences in thromboembolism (0.42% per patient-year vs. 0.09% per patient-year, p = 0.20) and all-cause mortality. CONCLUSIONS: DAPT was associated with higher rates of thromboembolism and valve thrombosis compared with control in the low-risk arm. International normalized ratios were safely maintained at 1.5 to 2.0 in high-risk patients, without differences in mortality or thromboembolic complications. (Randomized On-X Anticoagulation Trial [PROACT]; NCT00291525).

Coronary Revascularization With Single Versus Bilateral Mammary Arteries: Is It Time to Change?

BACKGROUND: Arterial conduits are preferred to venous conduits for coronary artery bypass grafting because of longer patency. A single internal mammary artery (SIMA) is used routinely. Bilateral internal mammary arteries (BIMA) are used less frequently. We sought to determine whether BIMA were superior to SIMA. METHODS: From our regional registry of consecutive open heart operations, we identified 47,984 patients who underwent isolated coronary artery bypass grafting from 1992 to 2014. Of the 1,482 BIMA patients, 1,297 were propensity matched to a cohort of SIMA patients. Short-term outcomes were compared using standard statistical techniques. Long-term survival was compared using Kaplan-Meier estimators and compared using a log-rank test. RESULTS: BIMA patients were younger and had fewer comorbid conditions than SIMA patients. After propensity weighting, BIMA and SIMA patients were well matched. There was no difference in in-hospital outcomes for BIMA versus SIMA patients for mortality (1.2% [n = 15] vs 0.8% [n = 10], p = 0.315), stroke (0.7% [n = 9] vs 0.7% [n = 9), p = 1.000), bleeding (2.2% [n = 28] vs 2.8% [n = 36], p = 0.311), or mediastinitis (0.8% [n = 10] vs 0.9% [n = 12], p = 0.667). The median follow-up was 12 years. Survival was better for BIMA than SIMA (adjusted hazard ratio, 0.79; 95% confidence interval, 0.69 to 0.91; p < 0.001). Survival curves began to separate after 5 years. At 15 years, the absolute difference in survival was 8.4%. CONCLUSIONS: In a large regional experience, BIMA is associated with no upfront risk of adverse events and improved long-term survival compared with SIMA. Our results indicate that BIMA conduits should be considered more frequently during coronary artery bypass grafting due to their demonstrated survival advantage.

ErbB2 promotes endothelial phenotype of human left ventricular epicardial highly proliferative cells (eHiPC).

The adult human heart contains a subpopulation of highly proliferative cells. The role of ErbB receptors in these cells has not been studied. From human left ventricular (LV) epicardial biopsies, we isolated highly proliferative cells (eHiPC) to characterize the cell surface expression and function of ErbB receptors in the regulation of cell proliferation and phenotype. We found that human LV eHiPC express all four ErbB receptor subtypes. However, the expression of ErbB receptors varied widely among eHiPC isolated from different subjects. eHiPC with higher cell surface expression of ErbB2 reproduced the phenotype of endothelial cells and were characterized by endothelial cell-like functional properties. We also found that EGF/ErbB1 induces VEGFR2 expression, while ligands for both ErbB1 and ErbB3/4 induce expression of Tie2. The number of CD31posCD45neg endothelial cells is higher in LV biopsies from subjects with high ErbB2 (ErbB2high) eHiPC compared to low ErbB2 (ErbB2low) eHiPC. These findings have important implications for potential strategies to increase the efficacy of cell-based revascularization of the injured heart, through promotion of an endothelial phenotype in cardiac highly proliferative cells.

Should Diabetes Be a Contraindication to Bilateral Internal Mammary Artery Grafting?

BACKGROUND: This study evaluates the influence of bilateral internal mammary artery (BIMA) versus single internal mammary artery (SIMA) grafting on postoperative morbidity and long-term survival among diabetic patients undergoing coronary artery bypass grafting (CABG). METHODS: A multicenter, retrospective analysis of 47,984 consecutive CABGs performed from 1992 to 2014 at 7 medical centers was conducted. Among the study population, 1,482 CABGs with BIMA were identified, and 1,297 BIMA patients were propensity-matched to 1,297 SIMA patients. The study cohort for this analysis, drawn from matched data, included 430 diabetic patients: 217 SIMA and 213 BIMA. The primary endpoint was long-term survival. Secondary endpoints included postoperative morbidity, length of stay, and in-hospital mortality. RESULTS: The median duration of follow-up was 9.3 (range, 4.3 to 13.9) years. Among propensity-matched diabetic patients, there was no significant difference in age, body mass index, or major baseline comorbidities. The groups were also well matched on the number of diseased coronary arteries and number of distal anastomoses performed. There was no difference in the rate of mediastinitis or sternal dehiscence (p = 0.503) or in-hospital mortality (p = 0.758) between groups. Both groups had a similar median length of stay of 5 (range, 4 to 7) days. Diabetic patients who received a BIMA had significantly improved long-term survival when compared with SIMA patients (hazard ratio 0.75 [95% confidence interval 0.57 to 0.98], p = 0.034). CONCLUSIONS: Among diabetics undergoing CABG, use of BIMA grafting does not result in increased in-hospital morbidity or mortality and confers a long-term survival advantage when compared with SIMA grafting. Thus, diabetic patients should be considered for BIMA grafting more frequently.

Does Use of Bilateral Internal Mammary Artery Grafting Reduce Long-Term Risk of Repeat Coronary Revascularization? A Multicenter Analysis.

BACKGROUND: Although previous studies have demonstrated that patients receiving bilateral internal mammary artery (BIMA) conduits during coronary artery bypass grafting have better long-term survival than those receiving a single internal mammary artery (SIMA), data on risk of repeat revascularization are more limited. In this analysis, we compare the timing, frequency, and type of repeat coronary revascularization among patients receiving BIMA and SIMA. METHODS: We conducted a multicenter, retrospective analysis of 47 984 consecutive coronary artery bypass grafting surgeries performed from 1992 to 2014 among 7 medical centers reporting to a prospectively maintained clinical registry. Among the study population, 1482 coronary artery bypass grafting surgeries with BIMA were identified, and 1297 patients receiving BIMA were propensity-matched to 1297 patients receiving SIMA. The primary end point was freedom from repeat coronary revascularization. RESULTS: The median duration of follow-up was 13.2 (IQR, 7.4-17.7) years. Patients were well matched by age, body mass index, major comorbidities, and cardiac function. There was a higher freedom from repeat revascularization among patients receiving BIMA than among patients receiving SIMA (hazard ratio [HR], 0.78 [95% CI, 0.65-0.94]; P=0.009). Among the matched cohort, 19.4% (n=252) of patients receiving SIMA underwent repeat revascularization, whereas this frequency was 15.1% (n=196) among patients receiving BIMA (P=0.004). The majority of repeat revascularization procedures were percutaneous coronary interventions (94.2%), and this did not differ between groups (P=0.274). Groups also did not differ in the ratio of native versus graft vessel percutaneous coronary intervention (P=0.899), or regarding percutaneous coronary intervention target vessels; the most common targets in both groups were the right coronary (P=0.133) and circumflex arteries (P=0.093). In comparison with SIMA, BIMA grafting was associated with a reduction in all-cause mortality at 12 years of follow-up (HR, 0.79 [95% CI, 0.69-0.91]; P=0.001), and there was no difference in in-hospital morbidity. CONCLUSIONS: BIMA grafting was associated with a reduced risk of repeat revascularization and an improvement in long-term survival and should be considered more frequently during coronary artery bypass grafting.

Closed Mitral Commissurotomy During Pregnancy in East Africa.

Cardiac surgeons traveling to East Africa on humanitarian surgical missions treat a large number of people of all ages with rheumatic heart disease. A patient with severe mitral stenosis with pulmonary edema in the second trimester of pregnancy was treated successfully with closed mitral commissurotomy in a hospital in rural Kenya. An operation from the late 1940s may regain prominence more than 70 years later in areas of the world with a high incidence of rheumatic heart disease and limited cardiology and cardiac surgery resources.

Premeasured Chordal Loops for Mitral Valve Repair.

Premeasured expanded polytetrafluoroethylene chordal loops with integrated sutures for attachment to the papillary muscle and leaflet edges facilitate correction of mitral valve prolapse. Configured as a group of 3 loops (length range 12 to 24 mm), the loops are attached to a pledget that is passed through the papillary muscle and tied. Each of the loops has 2 sutures with attached needles; these needles are passed through the free edge of the leaflet and then the sutures are tied to each other, securing the chordal loop to the leaflet.

Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial.

OBJECTIVE: Under Food and Drug Administration investigational device exemption, the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) has been testing the safety of less aggressive anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve. METHODS: In this first limb of the PROACT, patients with elevated risk factors for thromboembolism were randomized at 33 US centers to receive lower dose warfarin (test international normalized ratio [INR], 1.5-2.0) or continue standard warfarin (control INR, 2.0-3.0), 3 months after mechanical aortic valve replacement. The INR was adjusted by home monitoring; all patients received 81 mg aspirin daily. Adverse events were independently adjudicated. RESULTS: A total of 375 aortic valve replacement patients were randomized into control (n = 190) and test (n = 185) groups from September 2006 to December 2009. The mean age ± standard deviation was 55.2 ± 12.5 years; 79% were men; and 93% were in sinus rhythm preoperatively. Calcific degeneration was present in 67%; active endocarditis was excluded. Concomitant procedures included coronary artery bypass grafting (27%), aortic aneurysm repair (14%), and other (25%). The follow-up duration averaged 3.82 years (755.7 patient-years [pt-yrs] for control; 675.2 pt-yrs for test). The mean INR was 2.50 ± 0.63 for the control and 1.89 ± 0.49 for the test groups (P < .0001). The test group experienced significantly lower major (1.48% vs 3.26%/pt-yr; P = .047) and minor (1.32% vs 3.41%/pt-yr; P = .021) bleeding rates. The incidence of stroke, transient ischemic attack, total neurologic events, and all-cause mortality were similar between the 2 groups. CONCLUSIONS: INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism.